International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi has now developed a malaria vaccine 'Jaivac' and has transferred the technology to the Hyderabad based Bharat Biotech.

The new vaccine is a blood stage target to block invasion of the mosquito. The Institute has been engaged in the development of recombinant vaccines against the blood-stages of Plasmodium falciparum and P.vivax which are the two different parasites causing malaria. The former is a protozoan parasite and is one of the species of Plasmodium that cause malaria in humans. It is transmitted by the female Anopheles mosquitoes. The latter accounts for early 65 per cent of all malaria cases in India.

"Our approach focuses on conserved domains of parasite proteins that play important functional roles in erythrocyte invasion. The lead vaccine candidates are based on Plasmodium falciparum erythrocyte binding protein EBA175 and P.vivax Duffy binding protein and meroxoite surface protein 1(MSP1). Antibodies directed against these parasite proteins block erythrocyte invasion and inhibit parasite multiplication. Pre-clinical studies to identify optimal adjuvant formulations and developments of methods to produce the recombinant vaccine candidates were carried out at Intox, Pune," stated Dr Chetan E Chitnis, senior research scientist, Malaria Group, International Centre for Genetic Engineering and Biotechnology.

"We are developing a combination vaccine, Jaivac 1, which comprises of a physical mixture of recombinant PfF2 and PfMSP119 formulated with Montanide ISA720. Clinical grade JAIVAC-1 has been manufactured at Bharat Biotech, Hyderabad and is currently undergoing toxicology studies following which it will be tested in a phase-I human trial for safety and immunogenicity," he added.

Bharat Biotech has effectively manufactured three consistent batches of clinical grade material at 10L scale for preclinical toxicology studies under cGMP conditions. The safety and phase-I clinical trial studies are conducted at Sundergarh district in Orissa to evaluate the malaria candidate vaccinogens through collection of clinical, entomological and molecular epidemiological/immunological indicators from the study. Efficacy studies are being carried out in infants.

For the development of malaria vaccine, ICGEB Malaria Group faced challenges during the research of the vaccine on the complexity of the parasite lifecycle, immune evasion mechanism, lack of surrogate measures of protection, no predictive animal models and time consuming proof of concept field trials, informed Dr. Chitnis who was in Bangalore in connection with Bangalore Bio 2009. "Although India is strong in basic research there is need to have close interactions with the industry. There is need for a management structure in translational research and a regulatory environment with international norms," he said.

The global vaccine industry is expected to grow more than US$20 billion by 2010. India is becoming a major vaccine destination. The size of the Indian vaccine industry is around US$1 billion. The leading players in the space are Serum Institute, GlaxoSmithKline, Bharat Biotech International, Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, Panacea Biotec, Shantha Biotechnics, Indian Immunologicals, and Biological E Ltd.

The volume of business is growing with the introduction of newer vaccines and there is also considerable allocation of funds by the Department of Biotechnology to develop vaccines for malaria, AIDS, meningitis and Japanese encephalitis. Another major development on the vaccine front is that the World Health Organization has selected Serum Institute, Pune for production of the swine flu vaccine for the South East Asia region.